As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.
Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.
If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!
Job Title: YRC02F – Associate REMS Auditor
Brief Description: The Risk Evaluation and Mitigation Strategy [REMS] Associate Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. Audit support includes, but is not limited to, communication with stakeholders [healthcare settings, pharmacies, wholesalers/distributors], review of audit questionnaires and audit supporting documentation and appropriate documentation within the project-specific application.
Specific job duties:
Provide consistent and effective communication to all appropriate stakeholders as first line support/single point of contact with REMS stakeholders [healthcare settings, pharmacies, wholesalers/distributers]
Maintain accurate and complete documentation of all contacts.
Review project specific documentation that may include audit plans, project specific procedures, work instructions.
Complete review of all audit questionnaires assigned within the time constraints listed in the audit plan for a specific project.
Conduct document review of submitted documentation for completeness, accuracy, and REMS program compliance
Ensure follow-up of stakeholder audit documentation deficiencies and actions per client timelines.
Communicate with stakeholders via phone or email for documentation still outstanding
Identifies, evaluates, and addresses any audit findings
Articulate and explain audit results to stakeholders
Accurately complete the audit review form, either automated or manual, to ensure that documentation has been provided that meets the REMS program requirements.
Assist in development of continuous quality improvement with REMS Senior Auditors
Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented
Work collaboratively with other REMS Associate Auditors, REMS Auditors and REMS Senior Auditors to ensure that best practices are shared
Consistently completes SOP review and documentation within requested timelines.
Consistently completes client specific training and documentation within requested timelines.
Supervisory Responsibility: No supervisory responsibility.
Desired Skills and Qualifications:
Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience
Strong attention to detail and analytical skills
Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory requirements
Proficiency in Microsoft Office suite
Strong organizational and time management skills
Willingness to learn and adapt to new processes and regulations
Ability to work efficiently and prioritize tasks effectively.
Strong problem-solving abilities
Adherence to ethical standards and confidentiality protocols
Ability to maintain composure and professionalism under pressure
Benefits:
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
Here are some of the exciting perks UBC offers:
Remote opportunities
Competitive salaries
Growth opportunities for promotion
401K with company match
Tuition reimbursement
Flexible work environment
Discretionary PTO (Paid Time Off)
Paid Holidays
Employee assistance programs
Medical, Dental, and vision coverage
HSA/FSA
Telemedicine (Virtual doctor appointments)
Wellness program
Adoption assistance
Short term disability
Long term disability
Life insurance
Discount programs
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
#LI-JM1
#LI-REMOTE